Pyng Medical Corp.
Richmond, B.C., CA
Pyng Medical Corp. appears in FDA device records in Richmond, B.C., CA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Pyng Medical Corp. between 1997 and 2013. The busiest year on record is 2008, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130487 | FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE | FMI | Substantially Equivalent | |
| K100124 | FASTX STERNAL INTRAOSSEOUS DEVICE | FMI | Substantially Equivalent | |
| K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | |
| K072487 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | |
| K970380 | F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0228-2016 | MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs | Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging. | Class II | Terminated | |
| Z-2687-2011 | The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 2012. The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation. | Device failed to operate; the insertion of the infusion tube of the FASTx Sternal Intraosseous Device was not achieved in live subjects. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain